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OpenTrials
Completed

NCT Number: NCT02359669

Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities

The objective of the study is to explore the impact of a combined intervention including a growing up milk (GUM) fortified in micronutrients and cognitive stimulation on cognitive abilities, mother-child- interaction and behavior in children of 3 to 5 years from less enriched home environments.

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Key information

Conditions

Healthy

Age range

36 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Epidemiology and Evidence-Based Medicine, University of Indonesia-RSCM Hospital

Jarkarta, 10430, Indonesia

About this study

The objective of the study is to explore the impact of a combined intervention including a growing up milk (GUM) fortified in micronutrients and cognitive stimulation on cognitive abilities, mother-child- interaction and behavior in children of 3 to 5 years from less enriched home environments with HOME score less than 26. The control group will receive skimmed milk but no extra stimulation materials ( however, no restrictions on normal mother-child interaction). The cognitive abilities, mother-child interaction and child behavior will be assessed after a 6 months intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female children, age 3;0-4;11 years
  • Having obtained their legal representative's informed consent
  • Level of stimulation in their home environment score below 26 in HOME inventory
  • Normal cognitive development

Exclusion criteria

  • Neurological disorders
  • Food allergies (especially milk and soy allergy)
  • Documented lactose intolerance
  • Children with special nutritional needs
  • Children under chronic (more than 7 consecutive days) medications which may impact cognitive performance
  • Children not living in a family/children in foster homes
  • Subject who cannot be expected to comply with study procedures
  • Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study

Treatment and study plan

StimuLearn Intervention

Behavioral
  • StimuLearn apps
  • Cognitive questionnaires

Without StimuLearn intervention

Behavioral

Cognitive Questionnaires

Primary outcomes

  1. Cognitive abilities using Wechsler Pre-School and Primary Scale of Intelligence (WPPSI-IV), 4th Edition.

    Time frame: 24 weeks

    Blind assessment achieved by dedicated pyschologists at test center through use of the Wechsler Pre-School and Primary Scale of Intelligence (WPPSI-IV), 4th Edition questionnaire. This test is aimed at measuring overall cognitive abilities.

Secondary outcomes

  1. Parent-rating of child's development

    Time frame: 24 weeks.

    Measured by the Ages & Stages Questionnaire ( ASQ-3) which is a questionnaire for different age stages between 2 and 66 months of age to screen areas of communication, gross motor, fine motor, problem-solving and personal-social skills.

  2. Mother-Child interaction

    Time frame: 24 weeks

    Interaction is videotaped for 10 minutes sequences and analyzed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO).

  3. Child Behavior assessed by Child Behavior Checklist (CBCL 1.5 - 5 years)

    Time frame: 24 weeks

    This is a parent rated scale that obtains information about young children behaviors and is applicable for children aged 1.5 - 5 years.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Acronym: Stimulearn

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2015
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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